國家對(dui)于醫(yi)療(liao)器械有(you)著嚴格的分(fen)類：一類,二(er)類,三類。
第一類醫療(liao)器械有：基礎外科用刀(dao)(dao)《手術刀(dao)(dao)柄(bing)和刀(dao)(dao)片、皮(pi)片刀(dao)(dao)、疣體剝離刀(dao)(dao)、柳葉刀(dao)(dao)、鏟刀(dao)(dao)、剃毛刀(dao)(dao)、皮(pi)屑刮刀(dao)(dao)、挑刀(dao)(dao)、鋒刀(dao)(dao)、修腳刀(dao)(dao)、修甲刀(dao)(dao)、解剖刀(dao)(dao)等》。 第二類(lei)(lei)醫(yi)療(liao)器(qi)(qi)(qi)(qi)械(xie)(xie)：(a)普通診(zhen)察器(qi)(qi)(qi)(qi)械(xie)(xie)類(lei)(lei)(6820)：體(ti)溫計、血(xue)壓計;( b)物理治療(liao)及(ji)(ji)康復設備(bei)類(lei)(lei)(6826)：磁療(liao)器(qi)(qi)(qi)(qi)具(ju); (c)臨床(chuang)檢驗分析(xi)儀器(qi)(qi)(qi)(qi)類(lei)(lei)(6840)：家(jia)庭用(yong)(yong)(yong)(yong)(yong)(yong)血(xue)糖分析(xi)儀及(ji)(ji)試紙; (d)手(shou)術室(shi)、急救室(shi)、診(zhen)療(liao)室(shi)設備(bei)及(ji)(ji)器(qi)(qi)(qi)(qi)具(ju)類(lei)(lei)(6854)：醫(yi)用(yong)(yong)(yong)(yong)(yong)(yong)小型制(zhi)氧機(ji) 手(shou)提式氧氣發(fa)生(sheng)器(qi)(qi)(qi)(qi); (e)醫(yi)用(yong)(yong)(yong)(yong)(yong)(yong)衛(wei)生(sheng)材料(liao)(liao)及(ji)(ji)敷(fu)料(liao)(liao)類(lei)(lei)(6864)：匡用(yong)(yong)(yong)(yong)(yong)(yong)脫脂(zhi)棉、醫(yi)用(yong)(yong)(yong)(yong)(yong)(yong)脫脂(zhi)紗布; (f)醫(yi)用(yong)(yong)(yong)(yong)(yong)(yong)高分子材料(liao)(liao)及(ji)(ji)制(zhi)品(pin)類(lei)(lei)(6866)：避(bi)孕套(tao)、避(bi)孕帽等。第三類(lei)(lei)醫(yi)療(liao)器(qi)(qi)(qi)(qi)械(xie)(xie)：A、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)菌醫(yi)療(liao)器(qi)(qi)(qi)(qi)械(xie)(xie) 1、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)菌注射器(qi)(qi)(qi)(qi);2、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)輸(shu)(shu)液(ye)器(qi)(qi)(qi)(qi); 3、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)輸(shu)(shu)血(xue)器(qi)(qi)(qi)(qi); 4、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)麻醉穿刺包; 5、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)靜脈輸(shu)(shu)液(ye)針; 6、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)菌注射針; 7、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)塑料(liao)(liao)血(xue)袋; 8、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)采血(xue)器(qi)(qi)(qi)(qi); 9、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)滴定管式輸(shu)(shu)液(ye)器(qi)(qi)(qi)(qi)。 B、骨科植(zhi)入(ru)物醫(yi)療(liao)器(qi)(qi)(qi)(qi)械(xie)(xie) 1、外(wai)(wai)科植(zhi)入(ru)物關節假體(ti);(一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)菌醫(yi)療(liao)器(qi)(qi)(qi)(qi)械(xie)(xie)、助聽器(qi)(qi)(qi)(qi)、隱形眼鏡及(ji)(ji)護(hu)理用(yong)(yong)(yong)(yong)(yong)(yong)液(ye)、體(ti)外(wai)(wai)診(zhen)斷試劑、6846植(zhi)入(ru)材料(liao)(liao)和人(ren)工器(qi)(qi)(qi)(qi)官、6877介入(ru)器(qi)(qi)(qi)(qi)材除外(wai)(wai))等。三類(lei)(lei)醫(yi)療(liao)器(qi)(qi)(qi)(qi)械(xie)(xie)是(shi)最高級別的(de)(de)醫(yi)療(liao)器(qi)(qi)(qi)(qi)械(xie)(xie)，也(ye)是(shi)必須嚴格控制(zhi)的(de)(de)醫(yi)療(liao)器(qi)(qi)(qi)(qi)械(xie)(xie)，是(shi)指植(zhi)入(ru)人(ren)體(ti)，用(yong)(yong)(yong)(yong)(yong)(yong)于支持、維持生(sheng)命，對人(ren)體(ti)具(ju)有(you)潛在(zai)危(wei)險(xian)，對其安全性(xing)(xing)、有(you)效(xiao)性(xing)(xing)必須嚴格控制(zhi)的(de)(de)醫(yi)療(liao)器(qi)(qi)(qi)(qi)械(xie)(xie)。
為加強醫療(liao)器(qi)械(xie)(xie)生(sheng)產監(jian)(jian)督(du)(du)管(guan)理(li)(li)(li)，規范醫療(liao)器(qi)械(xie)(xie)生(sheng)產質(zhi)量(liang)管(guan)理(li)(li)(li)，根據(ju)《醫療(liao)器(qi)械(xie)(xie)監(jian)(jian)督(du)(du)管(guan)理(li)(li)(li)條例(li)》（國務(wu)院令(ling)650號(hao)）、《醫療(liao)器(qi)械(xie)(xie)生(sheng)產監(jian)(jian)督(du)(du)管(guan)理(li)(li)(li)辦(ban)法》（國家(jia)食(shi)品(pin)藥(yao)(yao)品(pin)監(jian)(jian)督(du)(du)管(guan)理(li)(li)(li)總局令(ling)第(di)7號(hao)），國家(jia)食(shi)品(pin)藥(yao)(yao)品(pin)監(jian)(jian)督(du)(du)管(guan)理(li)(li)(li)總局組織起草了《醫療(liao)器(qi)械(xie)(xie)生(sheng)產質(zhi)量(liang)管(guan)理(li)(li)(li)規范附(fu)錄(lu)無(wu)(wu)菌(jun)醫療(liao)器(qi)械(xie)(xie)》，現予(yu)以發(fa)布(bu)。本附(fu)錄(lu)是無(wu)(wu)菌(jun)醫療(liao)器(qi)械(xie)(xie)生(sheng)產質(zhi)量(liang)管(guan)理(li)(li)(li)規范的特殊要(yao)(yao)求(qiu)。無(wu)(wu)菌(jun)醫療(liao)器(qi)械(xie)(xie)生(sheng)產質(zhi)量(liang)管(guan)理(li)(li)(li)體系應當符合《醫療(liao)器(qi)械(xie)(xie)生(sheng)產質(zhi)量(liang)管(guan)理(li)(li)(li)規范》及本附(fu)錄(lu)的要(yao)(yao)求(qiu)。
要(yao)求(qiu)規定：無菌醫(yi)療器(qi)(qi)械(xie)(xie)生(sheng)產(chan)須滿足其質(zhi)量(liang)和(he)預期(qi)用途的(de)(de)(de)(de)(de)(de)要(yao)求(qiu)，最大限度地降低污(wu)染，并應當根據產(chan)品特性、生(sheng)產(chan)工(gong)藝和(he)設備等因素，確定無菌醫(yi)療器(qi)(qi)械(xie)(xie)潔(jie)凈(jing)室(shi)（區）的(de)(de)(de)(de)(de)(de)潔(jie)凈(jing)度級別，以保證醫(yi)療器(qi)(qi)械(xie)(xie)不受污(wu)染或(huo)能有(you)效排除(chu)污(wu)染。規定第二(er)部(bu)分特殊(shu)要(yao)求(qiu)2.2.2要(yao)求(qiu)：應當根據所生(sheng)產(chan)的(de)(de)(de)(de)(de)(de)無菌醫(yi)療器(qi)(qi)械(xie)(xie)的(de)(de)(de)(de)(de)(de)質(zhi)量(liang)要(yao)求(qiu)，確定在相應級別潔(jie)凈(jing)室(shi)（區）內進行生(sheng)產(chan)的(de)(de)(de)(de)(de)(de)過程，避免生(sheng)產(chan)中的(de)(de)(de)(de)(de)(de)污(wu)染。2.2.7 要(yao)求(qiu)：對于有(you)要(yao)求(qiu)或(huo)采用無菌操(cao)作(zuo)技(ji)術加(jia)工(gong)的(de)(de)(de)(de)(de)(de)無菌醫(yi)療器(qi)(qi)械(xie)(xie)（包括醫(yi)用材料(liao)），應當在10,000級下的(de)(de)(de)(de)(de)(de)局部(bu)100級潔(jie)凈(jing)室(shi)（區）內進行生(sheng)產(chan)。2.3.1要(yao)求(qiu)： 生(sheng)產(chan)設備、工(gong)藝裝(zhuang)備和(he)工(gong)位器(qi)(qi)具應當符合(he)潔(jie)凈(jing)環境控制和(he)工(gong)藝文件的(de)(de)(de)(de)(de)(de)要(yao)求(qiu)。
生產檢測依(yi)據以(yi)下文件執行：
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